6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA device recall Z-0360-2013 · posted 2012-11-19 · Terminated
Recall details
- Recalling firm
- NuVasive Inc
- Reason for recall
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Action taken
- Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected. Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 240 units total
- Distribution
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- Date initiated
- 2009-01-05
- Date posted
- 2012-11-19
- Date terminated
- 2012-11-19
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NUVASIVE SPHERX SYSTEM (K082332) | Nuvasive, Inc. | 2008-10-10 |